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Overview

Based on a 2003 workshop, this study describes current public and private programs and recommends ways to recruit and retain more women and underrepresented minorities into clinical research, especially physician-scientists and nurses. Federal sponsors should improve data collection, evaluate existing training programs, and increase the diversity of study section review panels. Public and private sponsors should create funding mechanisms with flexible career paths, and universities and professional societies should both play enhanced roles in fostering diversity. A significant push is needed to recruit minorities into nursing and provide more clinical research training for nurse-scientists, nursing students, and nursing faculty.

The increasing diversity and age of the U.S. population present new challenges for the U.S. clinical research community, whose role is to develop healthcare therapies and paradigms from the knowledge gained in basic research. A particularly acute challenge is the need to replenish and diversify its workforce, especially physician-scientists and nurses, whose small numbers are insufficient to meet the increasing need for clinical research. This project aimed to identify ways to recruit and retain more women and underrepresented minorities into the clinical research workforce to meet these challenges.

The study described in this volume incorporated a review of the current state of knowledge about the clinical research workforce and an information-gathering workshop of stakeholders-clinical researchers, medical school deans at academic health centers, and sponsors of clinical research. The study committee developed a set of questions to provide guidance to the workshop presenters and stimulate discussion among the participants:

What is the benefit of increasing the representation of women and underrepresented minorities in the clinical research workforce? Will increased diversityimprove delivery of the results of clinical research to minority communities?

What are the needs of the private and public sectors? Are the current approaches to training clinical investigators meeting the needs of academia, industry, and public health? Where is demand exceeding supply?

What training programs and career tracks appear to foster the development and retention of women and minorities in the clinical research workforce?

What research related to evaluation of existing training efforts needs to be funded? What are the important measures of outcome?

FINDINGS OF THE STUDY

The benefits of increased diversity in the clinical research workforce include increased clinical trial accrual of underrepresented minorities, more robust hypothesis generation for research questions relating to women and minority populations, and the potential for improved understanding and application of the results of clinical research to minority communities.

Unfortunately the study scope, as framed by the questions in the study charge, was much broader than that answerable by the available body of data. The committee found that the first three issues in the study charge could not be fully answered because of the lack of data on the clinical research workforce. This absence of data severely limited the ability of the committee to address questions regarding supply and demand and outcome measures for existing training efforts. Data on the private sector workforce are also not available, similarly limiting the committee's ability to address the study charge about the needs of the private sector.

The data collection needed for accurate characterization of the clinical research workforce is limited by the lack of a common definition of clinical research used across all sectors. The use of standard definitions among federal agencies, careful tracking of the subsets of clinical research, and systematic evaluation of the outcomes of existing training efforts would allow better monitoring of the clinical research workforce.

Physicians have less interest in research careers, and fewer trainees are opting for an M.D.-Ph.D. More women are earning their M.D.s, but fewer are opting for research careers despite continuing interest in academic positions. Underrepresented minorities earning M.D.s have increased numerically, but they are an infinitesimal proportion of the historical increase in M.D.s overall. The shortage of nursing faculty severely restricts the training of future nurses for clinical research and practice. Various training programs and career tracks foster the development and retention of women and minorities in the clinical research workforce, but more are needed for significant improvements in this area. Insufficient data on the clinical workforce limit understanding of its supply and demand, and an insufficient evaluation of existing programs limits assessment of success. Interdisciplinary research among basic and clinical scientists would broaden clinical research interest and should be encouraged.

RECOMMENDATIONS

The study committee clustered its recommendations around the following themes:

1. Adequate collection of the appropriate data;

2. Evaluation of the training landscape and mechanisms;

3. The special needs of nursing;

4. The pipeline and the career path for clinical researchers; and

5. The role of professional societies.

These themes contain systemic challenges that affect the entire clinical research enterprise, as well as specific challenges that should be addressed to improve the strength, character, and diversity of the workforce.

Data Needs

A fundamental difficulty in examining issues surrounding clinical research is the lack of data on the clinical research enterprise as a whole, including data on funding levels, training programs, and who participates in the workforce. It is a challenge to examine ways to sustain and replenish the clinical research workforce when the existing data do not permit an understanding of the state of the clinical research enterprise.

Recommendation

The National Institutes of Health (NIH) of the Department of Health and Human Services should initiate a process that will develop the consistent definitions and methodologies needed to classify and report clinical research spending for all federal agencies, with advice from relevant experts and stakeholders (federal sponsors and academic centers). Such a step would allow a better understanding of the training and funding landscape and would enable accurate data collection and analysis of the clinical research workforce.

Training Landscape and Mechanisms: An Evaluation

Clinical research training programs are supported by public (federal government) and private (industry, foundations) sources and are implemented at academic institutions. Continued support is vital to the health of the clinical research workforce, but awareness of and access to the programs are critical if the workforce is to thrive. The effectiveness of programs should be evaluated on a regular basis to determine their efficacy.

Recommendation

The Department of Health and Human Services should work with federal clinical research sponsors to identify and describe all federally sponsored training programs (both institutional and individual) for clinical research. The information provided should identify support for each level of training and each discipline across the spectrum of clinical research. Organized links to these programs should be available on a website, including programs offered at NIH, the Agency for Healthcare Research and Quality (AHRQ), the Veterans Administration (VA), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration. This resource should also be open to listing the institutional and individual programs offered by private sponsors for clinical research training.

The committee supports the development of the training website offered by NIH (http://www.training.nih.gov/careers/careercenter) and encourages NIH to modify and expand this resource to include a focus specifically on clinical research training programs.

Academic institutions should document and make publicly accessible the available programs for enhancing the participation of women and minority trainees in clinical research.

The sponsors of federal, foundation, and industry clinical research training programs should continue to support the existing efforts to train, develop, and sustain the careers of clinical researchers.

Federal agencies and academic institutions should periodically evaluate how well their current training programs are enhancing the racial and ethnic diversity of trainees and they should modify these programs as needed to increase the programs' effectiveness in clinical research.

Nursing Professionals

The continuing shortfall of nursing professionals is compounded in clinical research by the longer time required for specialized training, and the fewer numbers of nursing faculty involved in clinical research.

Recommendation

The need for appropriately trained nursing professionals in the clinical research workforce is especially urgent. A significant push is needed to increase the numbers of minorities entering the nursing profession. Additional attention should be paid to the clinical research training of nurse-scientists, nursing students, and nursing faculty at all academic levels.

The shortfall could be curtailed by expanding training efforts. These could include increasing fast-track B.S.N.-Ph.D. programs, training grants in clinical research, summer programs, fellowships, and training sabbaticals.

Replenishing the Pipeline: A Flexible Career Path

Given the long training period required for clinical research, entry points throughout a clinical research career path, not just at trainee levels, could increase the workforce. Additional efforts are needed to retain scientists in the clinical research workforce.

Recommendation

Academic institutions should develop strategies to attract mentors and reward mentorship in clinical research training. A special emphasis should be placed on the women and minorities who carry the greatest burden of mentorship responsibilities for women and minority scientists.

Recommendation

Federal sponsors of clinical research should amplify the existing funding mechanisms and create new ones that allow flexibility in career training, such as second-career programs, reentry mechanisms, and service payback agreements. These programs should be described on the NIH training website. In addition, other entry routes into the clinical research path, including short-term training programs, should be developed.

The Role of Professional Societies

Professional societies play a major role in the scientific community, as publishers of journals, sponsors of awards, and representatives of their scientific community.

Recommendation

Specialty medical and nursing societies should form a new consortium that would assume an enhanced role in fostering a diverse clinical research workforce.

Table of Contents

Contents

SUMMARY....................1
1 INTRODUCTION....................7
Lessons from the Business Sector....................10
Implications for Academic Health Centers....................10
The Focus of This Study....................11
2 THE CLINICAL RESEARCH WORKFORCE: ACROSS-THE-BOARD CHALLENGES....................14
NIH Investment in the Clinical Research Workforce....................15
Workforce Challenges for the Private Sector in Clinical Research....................22
The Shortage of Clinical Investigators....................23
Future Needs....................32
3 THE STATUS OF WOMEN AND UNDERREPRESENTED MINORITIES AND PROGRAMS OF SUPPORT....................33
Women Faculty....................33
Women Medical School Students....................37
Underrepresented Minority Faculty....................37
Underrepresented Minority Students in Medical Schools....................39
NIH Programs for Clinical Research and Minority Researchers....................42
Department of Veterans Affairs Programs....................47
Private Sources of Funding for Clinical Investigators....................49
Future Directions....................52
4 THE STATUS AND FUTURE ROLE OF ACADEMIC NURSING IN CLINICAL RESEARCH....................55
The Advancing Age of Nursing Faculty....................55
Preparing a Diverse and Representative Clinical Research Workforce....................57
National Institute of Nursing Research....................59
Future Needs at the Interface of Nursing and Clinical Research....................61
5 CONCLUSIONS ANDRECOMMENDATIONS....................66
Recommendations....................68
REFERENCES....................75
APPENDIXES A Biographies of Speakers....................87
B Workshop Guests....................95
C Workshop Agenda....................102
D Public Mechanisms for Clinical Research Training: Examples of Minority Research Training Programs....................107
E Public Mechanisms for Clinical Research Training....................116
F Examples of Pharmaceutical Company Training Programs....................122

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